NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 34 pharmaceutical companies such as NORVIUM BIOSCIENCE, ALKEM, ALMATICA and others. It is marketed under 3 brand names, including GABAPENTIN, GRALISE, HORIZANT. Available in 9 different strengths, such as 800MG, 600MG, 100MG and others, and administered through 4 routes including TABLET;ORAL, CAPSULE;ORAL, SOLUTION;ORAL and others.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"85141","ingredient":"GABAPENTIN ENACARBIL","trade_name":"HORIZANT","family_id":"46eee08b0f0b4c418de6","publication_number":"US8686034B2","cleaned_patent_number":"8686034","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-01-24","publication_date":"2014-04-01","legal_status":"Expired"} | US8686034B2 | 01 Apr, 2014 | Expired | 24 Jan, 2025 | |
| {"application_id":"85267","ingredient":"GABAPENTIN ENACARBIL","trade_name":"HORIZANT","family_id":"b88cf8b8b59a4b69b589","publication_number":"US6818787B2","cleaned_patent_number":"6818787","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-04-06","publication_date":"2004-11-16","legal_status":"Expired"} | US6818787B2 Molecular Formulation | 16 Nov, 2004 | Expired | 06 Apr, 2025 | |
| {"application_id":"85118","ingredient":"GABAPENTIN ENACARBIL","trade_name":"HORIZANT","family_id":"570ab39e949d4409be7e","publication_number":"US8114909B2","cleaned_patent_number":"8114909","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-04-11","publication_date":"2012-02-14","legal_status":"Granted"} | US8114909B2 | 14 Feb, 2012 | Granted | 11 Apr, 2026 | |
| {"application_id":"85165","ingredient":"GABAPENTIN ENACARBIL","trade_name":"HORIZANT","family_id":"46eee08b0f0b4c418de6","publication_number":"US8026279B2","cleaned_patent_number":"8026279","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-10","publication_date":"2011-09-27","legal_status":"Granted"} | US8026279B2 Molecular Formulation | 27 Sep, 2011 | Granted | 10 Nov, 2026 | |
| {"application_id":"85178","ingredient":"GABAPENTIN ENACARBIL","trade_name":"HORIZANT","family_id":"5ea2e30b8be14951a73c","publication_number":"US8795725B2","cleaned_patent_number":"8795725","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-10","publication_date":"2014-08-05","legal_status":"Granted"} | US8795725B2 Formulation | 05 Aug, 2014 | Granted | 10 Jun, 2029 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.